French Public Health Code
In forceI.-The production, including cultivation, manufacture, transport, import, export, possession, offer, transfer, acquisition and use of the following are prohibited:
1° Cannabis, its plant and resin, products containing them or those obtained from cannabis, its plant or resin;
2° Natural or synthetic tetrahydrocannabinols, their esters, ethers and salts, as well as salts of the aforementioned derivatives and products containing them.
II.The operations mentioned in I may be authorised when they concern medicinal products within the meaning of Article L. 5111-1, containing one of the substances mentioned in 1° and 2° of I and meeting one of the following conditions:
1° The medicinal product is the subject of a marketing authorisation granted in France in accordance with the provisions of Chapter I of Title II of this Book or by the European Union pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;
2° The medicinal product is the subject of one of the authorisations provided for in Articles L. 5121-12 and L. 5121-12-1, or of the registration provided for in article L. 5121-13 or of an import authorisation provided for in article L. 5124-13 in the event of a stock shortage or risk of a stock shortage of medicinal products.
III.-The operations mentioned in I, with the exception of supply and use, may also be authorised when they concern medicinal products within the meaning of article L. 5111-1 containing one of the substances mentioned in 1° and 2° of I and meeting the following two conditions:
1° The medicinal product meets the specifications laid down by order of the Minister for Health, issued on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products, relating in particular to its characteristics, composition, pharmaceutical form and indications;
2° The medicinal product is manufactured in compliance with the good manufacturing practices provided for in Article L. 5121-5 or any equivalent internationally recognised benchmark, in order to guarantee its quality, safety and intended therapeutic use.
IV. -The authorisations provided for in II and III are granted or withdrawn under the conditions set out in articles R. 5132-75 to R. 5132-78 to the establishments referred to in articles L. 5124-1 and L. 5138-1.
Cannabis plants may only be held and cultivated for the purpose of manufacturing medicinal products by growers who have entered into a contractual agreement to supply their production to one of these establishments.
V.-The holders of the authorisations referred to in II and III must report any intrusions into production sites, any damage and any security incident without delay to the police authorities, the regional health agency and the Agence nationale de sécurité du médicament et des produits de santé.
VI.-The technical procedures for the possession, cultivation, import, export, transport and storage of cannabis plants for medical purposes on national territory, including reporting procedures, are specified by order of the ministers responsible for agriculture, customs, the interior and health.
VII - Exemptions from the provisions set out in I may be granted for research and monitoring purposes by the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
